FDA 510(k) Application Details - K171584

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K171584
Device Name Catheter, Conduction, Anesthetic
Applicant B. Braun Medical Inc.
901 Marcon Blvd.
Allentown, PA 18109 US
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Contact Kimberly Smith
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 05/31/2017
Decision Date 12/22/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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